BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 2100647 · Received May 17, 2011

    Report

    Report Number
    3004209178-2011-03583
    Event Type
    Injury
    Date Received
    May 17, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 20, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S LEAD HAD PULLED BACK AT LEAST 9 MM SOMEWHERE BETWEEN THE POST-OPERATIVE X-RAY (TAKEN TO CONFIRM LOCATION) AND POST-OPERATIVE X-RAY TO CONFIRM NEUROSTIMULATOR PLACEMENT. A REVISION WAS PERFORMED WHERE THE LEAD WAS THEN PUSHED BACK TO THE CORRECT POSITION IN THE BRAIN. AFTER THE REVISION, THE PT WAS REPORTED AS DOING WELL WITH APPROPRIATE STIMULATION ACHIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention EXPLANTED:| EXTENSION: MODEL 7482A51, LOT# NHU221752V| IMPLANTED:| LEAD: MODEL 3389S-40, LOT# V514982| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 7438, LOT# NHL010654N